Tooth DiseasesPhase 3NCT04160247
Angulated Screw-retained Crowns Following Immediate Implant Placement
A Phase 3 study testing Immediate implant placement, Angulated screw-retained crowns placement and Cemented crowns placement in people with Tooth Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
There are two choices of restorations and implant abutments connection now: cemented and screw-retained.The excess cement, which would be difficult to completely remove, might lead to series of biological complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Diseases
- What is being tested?
- Immediate implant placement, Angulated screw-retained crowns placement and Cemented crowns placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2019to 20 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old and in good health;
- Single tooth implant (type 1) in the esthetic region;
- Patients with natural teeth adjacent to single implant crowns;
- Patients with periodontal treatment before implant surgery;
- The implants are from Nobel Biocare system with tapered link and the permanent restoration is a single crown and all-ceramic;
- Soft tissue in the implanting-and-adjacent areas is healthy and free of infection
Who cannot join
- Multiple implants in the esthetic region, or the restoration is a bridge
- Patients with bone augmentation procedures;
- Heavy smokers (>10 cigarettes/day);
- Medically compromised patients (American Society of Anesthesiologists (ASA) classification III-IV);
- Implants in an incorrect three-dimensional position (definition according to ITI VOL1);
- Uncontrolled diabetes mellitus;
- Unwilling to participate in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Cemented and Angulated Screw-retained Crowns Following Immediate Implant Placement: a Randomized Controlled Clinical Trials
There are two choices of restorations and implant abutments connection now: cemented and screw-retained.The excess cement, which would be difficult to completely remove, might lead to series of biological complications. The angulated screw channel (ASC) abutments, which recently introduced by Nobel Biocare , largely address the problem with visible screw access that may compromise esthetics. However, all of the present studies were clinical reports, thus the clinical efficacy of ASC abutments still needs the verification of evidence-based medicine with larger sample. Therefore, we designed a randomized controlled clinical trial study, aiming to verify the clinical efficacy of the ASC abutments by comparing screw-retained (with ASC abutments) single implant crowns with cemented ones in esthetic region.
- Conditions
- Tooth Diseases
- Being tested
- Immediate implant placement, Angulated screw-retained crowns placement, Cemented crowns placement
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placementProcedure or surgery
Implants are placed in fresh socket
Angulated screw-retained crowns placementProcedure or surgery
To insert the restorations by angulated screw systems
Cemented crowns placementProcedure or surgery
To cement the restorations onto the implant abutment
| Study group | Role | What they receive |
|---|---|---|
| Angulated screw-retained crown | Active comparator | Restorations are connected to the implants by angulated screw channel system Receives: Procedure: Immediate implant placement; Procedure: Angulated screw-retained crowns placement |
| Cemented crown | Placebo comparator | Restorations are cemented onto the implant abutment Receives: Procedure: Immediate implant placement; Procedure: Cemented crowns placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOP%
Percentage of bleeding on probing positive
Measured: from baseline to 1-year follow-up
Secondary outcomes (3)
PPD
Pocket probing depth
Measured: from baseline to 1-year follow-up
MBL
Marginal bone loss
Measured: from baseline to 1-year follow-up
PES
pink esthetic score
Measured: from baseline to 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start17 Jan 2019
- Primary completion20 Mar 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseasesStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160247
- Sponsor's protocol ID
- SH9-19-07
- Status last verified
- Jan 2021
- First submitted
- 8 Nov 2019
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Cemented and Angulated Screw-retained Crowns Following Immediate Implant Placement: a Randomized Controlled Clinical Trials
- ClinicalTrials.gov ID
- NCT04160247
- Acronym / sponsor ID
- SH9-19-07
- Conditions
- Tooth Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are two choices of restorations and implant abutments connection now: cemented and screw-retained.The excess cement, which would be difficult to completely remove, might lead to series of biological complications. The angulated screw channel (ASC) abutments, which recently introduced by Nobel Biocare , largely address the problem with visible screw access that may compromise esthetics. However, all of the present studies were clinical reports, thus the clinical efficacy of ASC abutments still needs the verification of evidence-based medicine with larger sample. Therefore, we designed a randomized controlled clinical trial study, aiming to verify the clinical efficacy of the ASC abutments by comparing screw-retained (with ASC abutments) single implant crowns with cemented ones in esthetic region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angulated screw-retained crown | Active comparator | Procedure: Immediate implant placement, Procedure: Angulated screw-retained crowns placementRestorations are connected to the implants by angulated screw channel system |
| Cemented crown | Placebo comparator | Procedure: Immediate implant placement, Procedure: Cemented crowns placementRestorations are cemented onto the implant abutment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years old and in good health;
- Single tooth implant (type 1) in the esthetic region;
- Patients with natural teeth adjacent to single implant crowns;
- Patients with periodontal treatment before implant surgery;
- The implants are from Nobel Biocare system with tapered link and the permanent restoration is a single crown and all-ceramic;
Key exclusion criteria (7 listed)
- Multiple implants in the esthetic region, or the restoration is a bridge
- Patients with bone augmentation procedures;
- Heavy smokers (>10 cigarettes/day);
- Medically compromised patients (American Society of Anesthesiologists (ASA) classification III-IV);
- Implants in an incorrect three-dimensional position (definition according to ITI VOL1);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate implant placementImplants are placed in fresh socket | Procedure or surgery | Angulated screw-retained crown, Cemented crown |
| Angulated screw-retained crowns placementTo insert the restorations by angulated screw systems | Procedure or surgery | Angulated screw-retained crown |
| Cemented crowns placementTo cement the restorations onto the implant abutment | Procedure or surgery | Cemented crown |
Primary outcome
BOP%
Time frame: from baseline to 1-year follow-up
Percentage of bleeding on probing positive
3 secondary outcomes
PPD
Time frame: from baseline to 1-year follow-up
MBL
Time frame: from baseline to 1-year follow-up
PES
Time frame: from baseline to 1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immediate implant placement, Angulated screw-retained crowns placement and Cemented crowns placement in people with Tooth Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOP% (time frame: from baseline to 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.